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Leadership SOSTM
Turning Failure into Success
Presented by: Steve Greer
GMP Consultant, Leadership Coach, Keynote Speaker
and Co-owner at Genesis Assist
Introduction
Steve A. Greer
Consultant, Leadership Coach, & Speaker
Recent “Graduate” of Procter & Gamble QA
External Engagement Leader
Leadership SOSTM
Turning Failure
into Success
Boat Captain
4
Boat Captain
5
Stormy Seas Image
6
8
Success = Ownership + Systems
PR Map
10
11
▪Cost: $500K+/mo
▪Service: 5% Missed
▪Moral: ?
50%Human
Toilet Image
13
Human Alerts and OOS
0%
20%
40%
60%
11/12 12/13 13/14 14/15
% Human Q Alerts
0%
20%
40%
60%
11/12 12/13 13/14 14/15
% Human OOS
70%
Business Results
0
5
10
15
20
25
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun
$14M
Inventory
Savings
16 pt Increase
in Employee
Survey
Perfect
Customer
Service
Eliminated
Past Due
Investigations
$20M+
Savings
Next Stop
Quality ManagementMaturity
Communication and Collaboration
Risk Management
Manufacturing Strategy and Operations
Productivity Optimization (5S)
Customer Experience
Quality Metrics
Advanced Analytics
Quality Culture
Leadership Commitment to Quality
Employee Ownership and Engagement
Sustainable Compliance
Business Continuity
Continual Improvement
Enhanced Pharmaceutical Quality System
Communication and Collaboration
Risk Management
Manufacturing Strategy and Operations
Productivity Optimization (5S)
Customer Experience
Quality Metrics
Advanced Analytics
Quality Culture
Leadership Commitment to Quality
Employee Ownership and Engagement
Sustainable Compliance
Business Continuity
Continual Improvement
Enhanced Pharmaceutical Quality System
3 Guaranteed Ways
to Fail
Approach to Human Error
21
Approach to Human Error
22
Approach to Human Error
23
Quality Our Consumers,
Customers, Regulators
and Employees trust
everywhere, every time.
P&G Quality Promise
Effective Leadership
25
Results
Accountability
Commitment
Conflict
TRUST
Success = Ownership + Systems
To make a mistake is
human, but to blame it on
someone else, that's even
more human.
“In late February, one or more workers somehow confused
the two during the production process, raising questions
about training and supervision.”
FDA 483 4/20/2021
Blame Cycle
Source: Ginette Collazo
Whose Fault is it?
Change Our Questions to Change Our Destiny
What Can I do
Differently?
Change Our Questions to Change Our Destiny
Success = Ownership + Systems
96%
“A bad system will beat a
good person every time”
W. Edwards Deming
▪ Read a single number wrong 2 10,000
▪ Read a clear 5 letter word wrong 3 10,000
▪ Read a checklist wrong 1 1,000
▪ Perform the wrong visual inspection 3 1,000
▪ Record information wrong 1 100
▪ Read an unclear 5 letter word wrong 3 100
▪ Fail to notice wrong position of valves 5 10
▪ Fail to act after 1 min in emergency 9 10
Human Error Rate
Dr. David J. Smith, “Reliability and Maintainability and Risk”
Procedures are the
single leading cause
of confusion
Are Your SOPs “Complete” or Easy to Apply?
Source: Talsico International
Martin VanTrieste – PDA/FDA 2016
SOPs Reinvented
Checklists
GEMBA – Leaders on the Floor
Solving the Wrong Problem
Investigate Human Performance DifferentlyInvestigate
technical problem not HP
Human Performance as a
“Root Cause”
Real Root Cause is not identified
Wrong problem is addressed
IA/CA/PA Ineffective
HEHE
5 ERRORS
Root cause analysis for
human error events rarely
gets to the real issues.
Ginette Collazo
Root Cause
The most basic cause (or causes)
that can reasonably be identified
that leadership has control to fix
and, when fixed, will prevent
(or significantly reduce the likelihood of)
the problem’s recurrence.
Adapted from Mark Paradies,
System Improvements
51Ginette Collazo
Human Memory Considerations
Adapted from Ginette Collazo
NOT A MOVIE HIGHLY COMPLEX, INTERCONNECTED
TEND TO ORDER AND STRUCTURE EVENTS
Interviews
Interviews are not about asking questions …
they are about stimulating memories
Mark Paradies, System Improvements
Success = Ownership + Systems
55
Contact Information
Steve A. Greer
LinkedIn: www.linkedin.com/in/steveagreer
www.GenesisAssistCoaching.com
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